510(k) K870631 ยท CGA Glucose Oxidase, Glucose
FAST GLUCOSE
| Applicant | Sclavo, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Mar 13, 1987 |
| Received | Feb 13, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870631
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.